Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
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ClinicalTrials.gov Identifier: NCT00226473 |
Recruitment Status : Unknown
Verified September 2005 by Dermatologic Cooperative Oncology Group.
Recruitment status was: Recruiting
First Posted : September 27, 2005
Last Update Posted : June 21, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Melanoma | Drug: Cisplatin, Vindesine, Dacarbazine (drugs) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma |
Study Start Date : | September 2001 |
Study Completion Date : | September 2005 |

- Overall survival
- Quality of life analysis
- Objective tumor response rate in study arm B
- Time to tumor progression
- Cost analysis

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histological diagnosis of metastatic melanoma (stage IV)
- progressive disease after first-line chemotherapy or immuno-chemotherapy
- Karnofsky-index > 60%
- informed consent
Exclusion Criteria:
- Uvea melanoma
- another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
- severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226473
Contact: Jens Ulrich, MD | +49-391-6715428 | jens.ulrich@medizin.uni-magdeburg.de |
Germany | |
Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim | Recruiting |
Mannheim, Baden-Württemberg, Germany, D-68167 | |
Contact: Dirk Schadendorf, MD +49-621-3832127 d.schadendorf@dkfz.de | |
Principal Investigator: Dirk Schadendorf, MD | |
Dept. of Dermatology, University Hospital Tuebingen | Recruiting |
Tuebingen, Baden-Württemberg, Germany, D-72076 | |
Contact: Claus Garbe, MD +49-7071-2980872 studienzentrum-derm-onko@med.uni-tuebingen.de | |
Principal Investigator: Claus Garbe, MD | |
Dept. of Dermatology, University of Frankfurt | Recruiting |
Frankfurt, Hessen, Germany, D-60590 | |
Contact: Konstanze Spieth, MD +49-69-6301-5311 konstanze.spieth@kgu.de | |
Principal Investigator: Konstanze Spieth, MD | |
Dept. of Dermatology, Medical Center Buxtehude | Recruiting |
Buxtehude, Niedersachsen, Germany, D-21641 | |
Contact: Peter Mohr, MD +49-4161-7036297 mohrpe@cs.com | |
Principal Investigator: Peter Mohr, MD | |
Dept. of Dermatology, Hildesheim | Recruiting |
Hildesheim, Niedersachsen, Germany, D-31134 | |
Contact: Michael Tronnier, MD +49-05121-894821 | |
Principal Investigator: Michael Tronnier, MD | |
Dept. of. Dermatology, University of Saarland, Homburg | Recruiting |
Homburg, Saaland, Germany, D-66421 | |
Contact: Wolfgang Tilgen, MD +49-6841-3800 hawtil@med-rz-sb.de | |
Sub-Investigator: Dorothea Tadler, MD | |
Dept. of Dermatology, University Otto von Guericke | Recruiting |
Magdeburg, Saxony-Anhalt, Germany, D-39120 | |
Contact: Jens Ulrich, MD +49-391-6715428 jens.ulrich@medizin.uni-magdeburg.de | |
Contact: Vassiliki Bekou, MD +49-391-6715264 vassiliki.bekou@medizin.uni-magdeburg.de | |
Sub-Investigator: Vassiliki Bekou, MD | |
Dept. of Dermatology, University of Schleswig-Holstein | Recruiting |
Kiel, Schleswig-Holstein, Germany, D-24105 | |
Contact: Axel Hauschild, MD +49-431-596-1613 ahauschild@dermatology.uni.kiel.de | |
Principal Investigator: Axel Hauschild, MD | |
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck | Recruiting |
Lübeck, Schleswig-Holstein, Germany, D-23538 | |
Contact: Sven Krengel, MD +49-451-5002517 svenkrengel@gm.net | |
Principal Investigator: Sven Krengel, MD | |
Dept. of Dermatology, Helios Clinic Erfurt | Recruiting |
Erfurt, Thuringia, Germany, 99012 | |
Contact: Ruthild Linse, MD +49-361-7814300 | |
Principal Investigator: Ruthild Linse, MD | |
Sub-Investigator: Yvonne Kellner, MD | |
Dept. of Dermatology, University of Jena | Recruiting |
Jena, Thuringia, Germany, D-07740 | |
Contact: Martin Kaatz, MD +49-3641-937302 kaatz@derma.uni-jena.de | |
Principal Investigator: Martin Kaatz, MD | |
Dept. of Dermatology, Charité Berlin | Recruiting |
Berlin, Germany, D-10098 | |
Contact: Uwe Trefzer, MD +49-30-450518063 uwe.trefzer@charite.de | |
Contact: Maja Hofmann, MD +49-30-450518063 maja.hofmann@charite.de | |
Principal Investigator: Uwe Trefzer, MD | |
Dept. of Dermatology, Vivantes Clinics | Recruiting |
Berlin, Germany, D-12351 | |
Contact: Peter Kohl, MD +49-30-60043601 p.kohl@vivantes.de | |
Principal Investigator: Peter Kohl, MD |
Principal Investigator: | Jens Ulrich, MD | Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany | |
Principal Investigator: | Axel Hauschild, MD | Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany | |
Study Director: | Peter Mohr, MD | Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany |
ClinicalTrials.gov Identifier: | NCT00226473 |
Other Study ID Numbers: |
ADO-MM-PAL8 |
First Posted: | September 27, 2005 Key Record Dates |
Last Update Posted: | June 21, 2006 |
Last Verified: | September 2005 |
malignant Melanoma Chemotherapy Metastasis standard palliative care best supportive care |
Melanoma Neoplasm Metastasis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes |
Dacarbazine Vindesine Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |